82/100 · Critical
Manufactured by Pharbest Pharmaceuticals, Inc.
Senna Adverse Events: High Incidence of Serious Reactions and Drug Interactions
41,603 FDA adverse event reports analyzed
Last updated: 2026-05-12
SENNA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharbest Pharmaceuticals, Inc.. Based on analysis of 41,603 FDA adverse event reports, SENNA has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for SENNA include NAUSEA, FATIGUE, CONSTIPATION, DYSPNOEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SENNA.
Senna has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 41,603 adverse event reports for this medication, which is primarily manufactured by Pharbest Pharmaceuticals, Inc..
The most commonly reported adverse events include Nausea, Fatigue, Constipation. Of classified reports, 84.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Senna reports a high incidence of serious reactions, particularly death and pneumonia.
Constipation, nausea, and fatigue are the most common reactions, but serious conditions like kidney injury and sepsis are also reported. Drug interactions and off-label use are noted as key safety signals, indicating potential risks when used with other medications. The majority of reports are from older adults, with a significant number of serious outcomes.
Patients taking Senna should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Senna has been associated with drug interactions and off-label use, which can increase the risk of adverse events. Healthcare providers should be cautious when prescribing Senna in combination with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Senna received a safety concern score of 82/100 (high concern). This is based on a 84.0% serious event ratio across 20,189 classified reports. The score accounts for 41,603 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 10,293, Male: 8,713, Unknown: 38. The most frequently reported age groups are age 75 (411 reports), age 65 (407 reports), age 76 (403 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 20,189 classified reports for SENNA:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Senna has been associated with drug interactions and off-label use, which can increase the risk of adverse events. Healthcare providers should be cautious when prescribing Senna in combination with other medications.
If you are taking Senna, here are important things to know. The most commonly reported side effects include nausea, fatigue, constipation, dyspnoea, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Report any new or worsening symptoms to your healthcare provider immediately. Do not use Senna for conditions it is not approved to treat. Be cautious when using Senna with other medications due to potential drug interactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory authorities have flagged Senna for serious adverse events, particularly in older adults. Patients should report any new or worsening symptoms to their healthcare provider and avoid using Senna for conditions it is not approved to treat.
The FDA has received approximately 41,603 adverse event reports associated with Senna. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Senna include Nausea, Fatigue, Constipation, Dyspnoea, Diarrhoea. By volume, the top reported reactions are: Nausea (1,391 reports), Fatigue (1,358 reports), Constipation (1,158 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Senna.
Out of 20,189 classified reports, 16,955 (84.0%) were classified as serious and 3,234 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Senna break down by patient sex as follows: Female: 10,293, Male: 8,713, Unknown: 38. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Senna adverse events are: age 75: 411 reports, age 65: 407 reports, age 76: 403 reports, age 71: 389 reports, age 73: 382 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Senna adverse event reports is Pharbest Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Senna include: Death, Vomiting, Pneumonia, Fall, Pyrexia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Senna to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Senna has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Senna reports a high incidence of serious reactions, particularly death and pneumonia.
Key safety signals identified in Senna's adverse event data include: High number of serious reactions (16,955 out of 20,189 total outcomes, 84%). Death and pneumonia are among the most severe reactions reported. Drug interactions and off-label use are frequent safety signals. A significant number of reports involve renal and cardiovascular issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Senna has been associated with drug interactions and off-label use, which can increase the risk of adverse events. Healthcare providers should be cautious when prescribing Senna in combination with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Senna.
Report any new or worsening symptoms to your healthcare provider immediately. Do not use Senna for conditions it is not approved to treat. Be cautious when using Senna with other medications due to potential drug interactions.
Senna has 41,603 adverse event reports on file with the FDA. Constipation, nausea, and fatigue are the most common reactions, but serious conditions like kidney injury and sepsis are also reported. The volume of reports for Senna reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory authorities have flagged Senna for serious adverse events, particularly in older adults. Patients should report any new or worsening symptoms to their healthcare provider and avoid using Senna for conditions it is not approved to treat. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with SENNA:
Drugs related to SENNA based on therapeutic use, drug class, or shared indications: